Zoledronate, Calcium, and Vitamin D in Preventing Bone Loss in Women Receiving Adjuvant Chemotherapy for Breast Cancer
Phase III Trial of Intravenous Zoledronic Acid (Zometa) in the Prevention of Bone Loss in Localized Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure
4 other identifiers
interventional
439
1 country
107
Brief Summary
RATIONALE: Zoledronate plus calcium and vitamin D may prevent bone loss in patients receiving adjuvant chemotherapy for breast cancer. It is not yet known which regimen is more effective in preventing bone loss. PURPOSE: This randomized phase III trial is comparing two regimens of zoledronate plus calcium and vitamin D to see how well they work in preventing bone loss in women who are receiving adjuvant chemotherapy for breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Dec 2001
Typical duration for phase_3 breast-cancer
107 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2001
CompletedStudy Start
First participant enrolled
December 1, 2001
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedJuly 19, 2016
July 1, 2016
5.2 years
August 10, 2001
July 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone mineral density in the lumbar spine
12 months from randomization
Secondary Outcomes (1)
Bone mineral density in the lumbar spine
36 months post randomization
Study Arms (2)
Zoledronic acid initial tx
EXPERIMENTALZoledronic acid + calcium + Vit D for 2 years, followed by Calcium + vit D for 1 year
Calcium + Vit D initial Tx
EXPERIMENTALCalcium + vitamin D for 1 year followed by zoledronic acid + calcium + vit D for 2 years
Interventions
1000 mg PO per day
400 IU PO per day
4 mg IV infusion q 3 months, months 1-24 in Zoledronic acid initial tx arm and months 13-36 in calcium + vit D initial tx arm
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (107)
Arroyo Grande Community Hospital
Arroyo Grande, California, 93420, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658, United States
El Camino Hospital
Mountain View, California, 94040, United States
Naval Medical Center - San Diego
San Diego, California, 92134, United States
Veterans Affairs Medical Center - San Diego
San Diego, California, 92161, United States
Kent General Hospital at Bayhealth Medical Center
Dover, Delaware, 19901, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713, United States
St. Francis Hospital
Wilmington, Delaware, 19805, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Washington Cancer Institute at Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, 33458, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Cancer Research Network, Incorporated
Plantation, Florida, 33324, United States
Cleveland Clinic Florida - Weston
Weston, Florida, 33331, United States
St. Joseph Medical Center
Bloomington, Illinois, 61701, United States
Graham Hospital
Canton, Illinois, 61520, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470, United States
Eureka Community Hospital
Eureka, Illinois, 61530, United States
Galesburg Clinic
Galesburg, Illinois, 61401, United States
Galesburg Cottage Hospital
Galesburg, Illinois, 61401, United States
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, 61401, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Hopedale Medical Complex
Hopedale, Illinois, 61747, United States
Kewanee Hospital
Kewanee, Illinois, 61443, United States
La Grange Memorial Hospital
La Grange, Illinois, 60525, United States
McDonough District Hospital
Macomb, Illinois, 61455, United States
BroMenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center
Normal, Illinois, 61761, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699, United States
Community Hospital of Ottawa
Ottawa, Illinois, 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, 61554, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61615, United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois Valley Community Hospital
Peru, Illinois, 61354, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
St. Margaret's Hospital
Spring Valley, Illinois, 61362, United States
Valley Cancer Center
Spring Valley, Illinois, 61362, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350, United States
Suniti Medical Corporation
Merrillville, Indiana, 46410, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Saint Joseph Regional Medical Center
South Bend, Indiana, 46617, United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722, United States
Iowa Blood and Cancer Care
Cedar Rapids, Iowa, 52402, United States
St. Luke's Hospital
Cedar Rapids, Iowa, 52402, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
Central Maine Medical Center
Lewiston, Maine, 04240, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, 04074, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore, Maryland, 21237, United States
Union Hospital Cancer Center at Union Hospital
Elkton MD, Maryland, 21921, United States
Sturdy Memorial Hospital
Attleboro, Massachusetts, 02703, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Faulkner Hospital
Boston, Massachusetts, 02130, United States
Bethke Cancer Center at Emerson Hospital
Concord, Massachusetts, 01742, United States
Lowell General Hospital
Lowell, Massachusetts, 01854, United States
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, 55455, United States
Saint Luke's Hospital
Chesterfield, Missouri, 63017, United States
CCOP - Kansas City
Kansas City, Missouri, 64131, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Missouri Baptist Cancer Center
St Louis, Missouri, 63131, United States
Missouri Cancer Care, P. C. - Wentzville
Wentzville, Missouri, 63385, United States
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, 68114, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett, New Hampshire, 03106, United States
Lakes Region General Hospital
Laconia, New Hampshire, 03246, United States
Elliot Regional Cancer Center
Manchester, New Hampshire, 03103, United States
Oncology Center at St. Joseph Hospital
Nashua, New Hampshire, 03060, United States
Jersey City Medical Center at Liberty Health
Jersey City, New Jersey, 07302, United States
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
Voorhees Township, New Jersey, 08043, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Nalitt Cancer Institute at Staten Island University Hospital
Staten Island, New York, 10305, United States
CCOP - Hematology-Oncology Associates of Central New York
Syracuse, New York, 13057, United States
Community General Hospital of Greater Syracuse
Syracuse, New York, 13215, United States
Faxton Regional Cancer Center
Utica, New York, 13502, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, 28801, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534, United States
Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
Lenoir Memorial Cancer Center
Kinston, North Carolina, 28501, United States
Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, 28374, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, 43210-1240, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224-1791, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
Miriam Hospital at Lifespan
Providence, Rhode Island, 02906, United States
CCOP - Greenville
Greenville, South Carolina, 29615, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390, United States
Southwestern Vermont Regional Cancer Center
Bennington, Vermont, 05201, United States
Mountainview Medical
Berlin Corners, Vermont, 05602, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05401, United States
Community Cancer Center at Rutland Regional Medical Center
Rutland, Vermont, 05701, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
St. Mary's Regional Cancer Center at St. Mary's Medical Center
Huntington, West Virginia, 25702, United States
Related Publications (2)
Shapiro CL, Halabi S, Gibson G, et al.: Effect of zoledronic acid (ZA) on bone mineral density (BMD) in premenopausal women who develop ovarian failure (OF) due to adjuvant chemotherapy (AdC): first results from CALGB trial 79809. [Abstract] J Clin Oncol 26 (Suppl 15): A-512, 2008.
RESULTAdams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
PMID: 38979716DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Charles L. Shapiro, MD
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2001
First Posted
January 27, 2003
Study Start
December 1, 2001
Primary Completion
March 1, 2007
Study Completion
February 1, 2009
Last Updated
July 19, 2016
Record last verified: 2016-07